The Brazilian Health Regulatory Agency, ANIVSA, has published new regulations to clarify the changes to its GMP inspection which will provide more clarification and help expediteBrazilian Good Manufacturing Practice (BGMP) certifications.
Following their recent publication of RDC 179/2017 which establishes a risk-based BGMP inspection, ANVISA has now issued a new regulation, RDC 183/2017 (link in Portuguese), that establishes the inspection program and administrative procedures for granting GMP certificates for foreign establishments. The new rules detail the issues such as:
- BGMP risk-based inspection approach rules
- List of establishments requiring BGMP certification for commercialisation
- Documents registrants must submit to undergo BGMP inspection and certification
- Transition rules and policies for moving to the new BGMP inspection system